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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Subject device: Vinyl Exam Gloves, Powder Free, Clear
Device Class: Class I
Regulation number: 21 CFR 880.6250
Product code: LYZ
Length: 230 mm min
Width: 94 mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner

This document is a 510(k) Premarket Notification from the FDA regarding "Vinyl Exam Gloves, Powder Free, Clear". It's a regulatory submission for a medical device and does not describe an AI/ML powered device or a study related to AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device. The document is about physical properties and biocompatibility of examination gloves, not an AI system.

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